Drug Firm "Had Not Tested on Humans Before" By Jeremy Laurance and Tony Paterson The Independent UK 17 March 2006

The German company whose drug trial has left six men fighting for their lives after it went badly wrong had never tested its products on humans before.

Thomas Hanke, the chief scientific officer of TeGenero, based in Wurzburg, said the company was "devastated" by the news. The new medicine, known as TGN 1412,
had shown no safety problems in laboratory trials or animal tests, he said.

But it emerged yesterday that the American testing company Parexel, which TeGenero had commissioned to run the trial, had initially been refused permission to test the drug in Germany. The Paul Ehrlich Institute in Germany, which was responsible for overseeing the company's proposed drug-testing programme, sent back its project with a lengthy list of deficiencies which it demanded be corrected before testing was allowed.

German media reports said yesterday that Parexel was eventually granted permission to carry out the tests in Germany after the deficiencies had been ironed out, but by then the company had approached the British medical authorities for permission to carry out tests in the UK.

Lawyers acting for one of the victims at Northwick Park hospital, north-west London, raised doubts about the animal experiments that TeGenero claimed to have carried out. Ann Alexander, of the solicitors' firm Alexander Harris, whose 29-year-old client is on life support, said: "There is confusion about whether the drug had been tested successfully and safely on animals before the tests on these volunteers."

In one meeting with the families of those involved in the trial, company representatives said the drug had been tested on monkeys and dogs and one of the dogs had died, she said. In a second meeting, they were told tests had been carried out on monkeys and rabbits and the company had denied testing the drug on dogs. "It has been a devastating tragedy and these mixed messages cause great concern," she said.

Yesterday, Mr Hanke said that the drug had been tested on monkeys and rabbits and that no animals had died.